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News

CFC inhaler ban spurs innovation and drives market growth

Kalorama Information : 09 September, 2008  (Company News)
Government regulation that bans the use of chlorofluorocarbon (CFC) in inhalers is causing major changes in the respiratory disposables and reusable respiratory accessories market reveals a new report from Kalorama Information entitled ‘World Market for Respiratory Equipment and Disposables, 3rd Edition’.
Asthma and chronic obstructive pulmonary disease (COPD) afflict about 181 million and 44.2 million people respectively worldwide and incidence rates continue to increase. Inhalers make up the lion’s share of the $36 billion market for respiratory devices, with 45 percent of the total, and are expected to enjoy a strong 9.8 percent growth rate through 2012, spurred in part by new product innovations following a ban on CFC-based inhalers.

More than 95 percent of inhalers contain ozone depleting CFC as a propellant. In order to abide by international environmental guidelines, the US released a new policy in 2005 that CFCs must be removed from inhalers by December 31, 2008 and replaced with hydrofluoroalkane (HFA). All HFA inhalers had to undergo extensive clinical development and new drug applications to the FDA. These new non-CFC inhalers will not see generic competition until they begin coming off patent starting in 2010 and therefore cost about twice as much as CFC inhalers.

“Compliance could be a blessing in disguise for inhaler companies,” said Kalorama Information’s analyst Joe Constance. “Until December 2007, companies with CFC-based products were allowed to market their product, so they have had sufficient time to take the necessary steps to shift towards HFA based products. And the companies did not need to make any significant changes in their manufacturing processes in order to abide by this new government regulation.”

Inhaler equipment suppliers and pharmaceutical companies have been collaborating to face the phase-out and preparing themselves by installing the capabilities for HFA-based products in terms of stability testing and product compatibility tests.
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